Head-to-head data, presented at OPTIONS XII for
the Control of Influenza Conference, demonstrates advantage of
sa-mRNA over conventional mRNA in duration of immune response;
Results highlight CSL and Arcturus Therapeutics’ commitment to
advancing COVID-19 vaccine innovation to protect public health.
Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and
self-amplifying messenger RNA (sa-mRNA) pioneer Arcturus
Therapeutics (Nasdaq: ARCT) today announced the results of a
head-to-head study demonstrating that self-amplifying (sa-mRNA)
COVID-19 vaccine maintained superior immunogenicity compared to the
conventional mRNA vaccine Comirnaty® for up to one year against
Wuhan-Hu-1, Omicron BA.4-5 and certain other variants, and at
one-sixth the dose of the comparator (5 μg vs 30 μg,
respectively).
The data, presented as a poster at the OPTIONS XII for the
Control of Influenza conference, highlights 12-month follow-up
analysis of the Phase 3 trial conducted in Japan by Meiji Seika
Pharma, evaluating a booster dose of ARCT-154, showing that the
vaccine elicited superior immunogenicity and antibody persistence
over Comirnaty® for up to 12 months postvaccination, against
multiple SARS-CoV-2 strains and in both younger and older adult age
groups.
“The 12-month results from the ARCT-154 study continue to
establish the durability of immune response from this
self-amplifying mRNA vaccine and reinforce the ability of this
vaccine to provide protection against COVID-19 at lower doses
compared to conventional mRNA vaccines,” said Jonathan Edelman,
M.D., Senior Vice President, Vaccines Innovation Unit, CSL. “We are
proud to showcase at the 2024 OPTIONS conference with these
important data about the first sa-mRNA COVID-19 vaccine now
approved in Japan.”
Additional data presented by CSL and Arcturus finds that the
bivalent formula, ARCT-2301, developed on the same platform as
ARCT-154, induces superior immunogenicity over conventional
bivalent mRNA vaccine Comirnaty® that persists against key variants
up to six months postvaccination.
“The recent surge in COVID-19 infections and the emerging new
variants illustrate the critical need for vaccines that provide a
longer duration of protection compared to conventional mRNA
vaccines,” said Igor Smolenov, M.D., Ph.D. Chief Development
Officer of Arcturus Therapeutics. "These compelling new studies
reaffirm that these sa-mRNA vaccines have the potential to offer
potent protection against COVID-19.”
The COVID-19 vaccine from this sa-mRNA platform targeted against
the JN.1 variant is approved in Japan for immunization against
COVID-19 in adults 18 years and older and is being sold under the
trade name KOSTAIVE®.
ARCT-154 12-month Study Design and Results
The randomized, double-blind, active-controlled Phase 3 study
was conducted at 11 clinical sites in Japan. The study enrolled 828
adults who had previously been fully immunized with three doses of
mRNA vaccine(s). Participants were randomized equally to receive a
booster dose of either ARCT-154 or Comirnaty®. Immune responses
were measured as neutralizing antibodies against the Wuhan-Hu-1 and
Omicron BA.4-5 strains in sera obtained at Day 1 before booster
vaccination, and Days 29, 91, 181, and 361 after vaccination of
participants who were seronegative for SARS-CoV-2 nucleocapsid
protein (N-protein), considered to be an indicator of recent
COVID-19 infection. At the same timepoints neutralizing antibodies
against Delta, Omicron BA.2, Omicron BA.2.86, and Omicron XBB.1.5.6
variants were measured in subsets of participants (~30 per group).
Responses are expressed as group geometric mean titers (GMT) with
95% confidence intervals, and geometric mean titer ratio (GMTR)
between the two vaccine groups at each timepoint.
At Day 29, neutralizing antibodies (GMTs unadjusted) against the
Wuhan-Hu-1 strain in ARCT-154 recipients (n = 378) were superior to
those in the Comirnaty® group (n = 374): GMT = 5390 (95% CI:
4899–5931) vs. 3738 (3442–4060), a GMT ratio of 1.44 (1.27–1.64).
This advantage persisted through all time points. At Day 361
(unadjusted) GMTs were 3396 (3019–3821) and 1771 (1532–2047) in
ARCT-154 (n = 272) and Comirnaty® (n = 266) groups, a GMT ratio of
1.92 (1.59–2.31). Differences were also observed in responses
against Omicron BA.4-5, with GMT ratios of 1.31 (1.07–1.59) at Day
29 and 1.89 (1.42– 2.50) at Day 361. A subset of subjects who were
seronegative for N-protein displayed similar differences in immune
responses between ARCT-154 and Comirnaty® against the Delta,
Omicron BA.2, BA.2.86, and XBB.1.5.6 variants at Day 361. The GMT
ratios were 1.88 (0.79–4.49) against Delta, 2.34 (1.06–5.17)
against Omicron BA.2, 2.51 (1.00–6.31) against Omicron BA.2.86 and
2.81 (1.09–7.28) against Omicron XBB.1.5.6.
Bivalent 6-month Study Design and Results
In this randomized, multicenter, Phase 3, observer-blind,
active-controlled trial in Japan, fully-immunized (3‒5 doses of
mRNA vaccine) adults were randomized 1:1 to receive a booster dose
of ARCT-2301 or Comirnaty® Original/BA.4-5. The primary objective
was to demonstrate non-inferiority of the immunogenicity of
ARCT-2301 vs. Comirnaty® Original/BA.4-5 at Day 29 as neutralizing
antibody GMT and seroresponse rates (SRR) against Omicron BA.4-5.
Key secondary outcomes included titers of neutralizing antibodies
against Wuhan-Hu-1 and Omicron XBB.1.5.
Between September and November 2023, 930 men and women (19‒80
years) with at least three prior mRNA COVID-19 vaccinations were
enrolled at nine medical centers in Japan and administered
ARCT-2301 (n = 465) or Comirnaty® Original/BA.4-5 (n = 465)
boosters. At Day 29 ARCT-2301 (n = 398) induced superior
neutralizing antibody responses vs. Comirnaty® (n = 405) against
Omicron BA.4-5 (GMT ratio 1·49 [95% CI: 1.26–1.76], SRR difference
7.2% [95% CI: 0.6–13.7]), and against Wuhan-Hu-1 (GMT ratio 1.45
[1.28–1.63], SRR difference 12.5% [5.9–19.0]). The difference
persisted through six months with GMT ratios of 2.17 (95% CI:
1.75-2.69) and 1.98 (95% CI: 1.69-2.31), respectively. Antibody
responses against Omicron XBB.1.5 were also higher after ARCT-2301
vs. Comirnaty® (GMT ratio 1.63 [1.36–1.94], SRR difference 16.7%
[10.1–23.2]).
About sa-mRNA
mRNA vaccines help protect against infectious diseases by
providing a blueprint for cells in the body to make a protein to
help our immune systems recognize and fight the disease. Unlike
standard mRNA vaccines, self-amplifying mRNA vaccines instruct the
body to make more mRNA and protein to boost the immune
response.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company
with a dynamic portfolio of lifesaving medicines, including those
that treat hemophilia and immune deficiencies, vaccines to prevent
influenza, and therapies in iron deficiency and nephrology. Since
our start in 1916, we have been driven by our promise to save lives
using the latest technologies. Today, CSL – including our three
businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides
lifesaving products to patients in more than 100 countries and
employs 32,000 people. Our unique combination of commercial
strength, R&D focus and operational excellence enables us to
identify, develop and deliver innovations so our patients can live
life to the fullest. For inspiring stories about the promise of
biotechnology, visit CSLBehring.com/Vita and follow us on
Twitter.com/CSL. For more information about CSL, visit
www.CSL.com.
About Arcturus
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global mRNA
medicines and vaccines company with enabling technologies: (i)
LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology
(sa-mRNA) and (iii) mRNA drug substance along with drug product
manufacturing expertise. Arcturus developed KOSTAIVE®, the first
self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world
to be approved. Arcturus has an ongoing global collaboration for
innovative mRNA vaccines with CSL Seqirus, and a joint venture in
Japan, ARCALIS, focused on the manufacture of mRNA vaccines and
therapeutics. Arcturus' pipeline includes RNA therapeutic
candidates to potentially treat ornithine transcarbamylase (OTC)
deficiency and cystic fibrosis (CF), along with its partnered mRNA
vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus'
versatile RNA therapeutics platforms can be applied toward multiple
types of nucleic acid medicines including messenger RNA, small
interfering RNA, circular RNA, antisense RNA, self-amplifying RNA,
DNA, and gene editing therapeutics. Arcturus' technologies are
covered by its extensive patent portfolio (over 400 patents and
patent applications in the U.S., Europe, Japan, China, and other
countries). For more information, visit www.ArcturusRx.com. In
addition, please connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. Any statements, other than statements of historical
fact included in this press release, are forward-looking
statements, including those regarding strategy, future operations,
the likelihood that KOSTAIVE will provide a longer duration of
protection, the likelihood and timing of future approvals of
KOSTAIVE anywhere in the world including Europe, the plans to
submit additional regulatory filings and timing thereof, that
preclinical or clinical data will be predictive of future clinical
results, and the impact of general business and economic
conditions. Arcturus may not actually achieve the plans, carry out
the intentions or meet the expectations or projections disclosed in
any forward-looking statements such as the foregoing and you should
not place undue reliance on such forward-looking statements. These
statements are only current predictions or expectations, and are
subject to known and unknown risks, uncertainties, and other
factors that may cause our or our industry’s actual results, levels
of activity, performance or achievements to be materially different
from those anticipated by the forward-looking statements, including
those discussed under the heading "Risk Factors" in Arcturus’ most
recent Annual Report on Form 10-K, and in subsequent filings with,
or submissions to, the SEC, which are available on the SEC’s
website at www.sec.gov. Except as otherwise required by law,
Arcturus disclaims any intention or obligation to update or revise
any forward-looking statements, which speak only as of the date
they were made, whether as a result of new information, future
events or circumstances or otherwise.
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CSL Media Contacts: Sue Thorn Mobile: 617 799 3151 Email:
sue.thorn@cslbehring.com
Australia: Jimmy Baker Mobile: +61 450 909 211 Email:
Jimmy.Baker@csl.com.au
Asia Pacific: Hamish Walsh +61 422 424 338 Email:
hamish.walsh@seqirus.com
Arcturus Media Contact: Neda Safarzadeh VP, Head of
IR/PR/Marketing Email: IR@arcturusrx.com
Arcturus Therapeutics (NASDAQ:ARCT)
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